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RECRUITINGPhase 4INTERVENTIONAL

Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy

GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.

Who May Be Eligible (Plain English)

Who May Qualify: - Have a physician diagnosis of PC - Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor) - Elevated BMI 1. ≥30kg/m2 or 2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia Who Should NOT Join This Trial: - Type 1 diabetes - Taking a GLP-1 RA - \<18 years of age - History of pancreatitis - Personal or family history of medullary cancer of the thyroid - Multiple endocrine neoplasia type 2 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Have a physician diagnosis of PC * Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor) * Elevated BMI 1. ≥30kg/m2 or 2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia Exclusion Criteria: * Type 1 diabetes * Taking a GLP-1 RA * \<18 years of age * History of pancreatitis * Personal or family history of medullary cancer of the thyroid * Multiple endocrine neoplasia type 2

Treatments Being Tested

DRUG

Semaglutide Pen Injector

The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.

Locations (1)

Juravinski Cancer Centre
Hamilton, Ontario, Canada